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HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE

Clinical trials are investigating HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE in people with colorectal cancer and cancer cachexia. These studies aim to assess effects on body weight, safety, and tolerability. The trial data describe a randomized, double-blind, placebo-controlled Phase 2 study.

Table of Contents

Trial overview

The available trial data show one study of HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE in people with colorectal cancer with cancer cachexia.[1] The study is designed to compare the treatment with a placebo, which helps researchers see whether any changes are likely due to the study drug rather than chance.[1]

Study design and phase

This is an interventional study, meaning researchers give a study treatment and then measure results.[1] It is a Phase 2 trial, which usually looks at early signs of benefit while also continuing safety checks.[1]

The study is randomized, double-blind, and placebo-controlled.[1] Randomized means participants are assigned by chance, double-blind means neither the participants nor the study team knows who gets which treatment, and placebo-controlled means one group receives an inactive comparison treatment.[1]

Who can participate

The trial is for participants with colorectal cancer who also have cancer cachexia.[1] Cancer cachexia is a condition linked to cancer-related weight loss and muscle loss, so the study population is focused on people with this specific problem.[1]

The planned enrollment is 136 participants.[1] This number gives a sense of the study size, although the source data do not provide more detailed inclusion or exclusion rules.[1]

What is being measured

The main outcome is change from baseline in body weight at Week 12.[1] Baseline means the starting point before treatment begins, so researchers will compare weight later with the starting weight.[1]

The study also measures treatment-emergent adverse events, or health problems that appear during the study after treatment starts.[1] These events are described by type, frequency, severity, timing, seriousness, and whether they seem related to the study drug.[1]

The brief summary says Part A evaluates the effect of NGM120 compared with placebo on body weight, and Part B evaluates safety and tolerability.[1] The source data use the name NGM120 for the intervention in this study.[1]

Trial status and size

The trial status is listed as Authorised.[1] This means the study has been approved to proceed in the source record, but the data provided do not show study results.[1]

The trial plans to enroll 136 people, which makes it a moderate-sized Phase 2 study.[1] The source information includes one trial record, so the current overview is based on that single study only.[1]

Patient-friendly terms

  • Body weight change means the study checks whether participants gain, lose, or keep weight over time.[1]

  • Safety means whether unwanted health problems happen during the study.[1]

  • Tolerability means how well people can handle the treatment in daily life without major difficulties.[1]

  • Placebo means a look-alike treatment used for comparison, but it does not contain the active study drug.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07033026 Phase 2 Colorectal Cancer with Cancer Cachexia Authorised 136

FAQ

  • What condition is being studied in the trial? The trial is studying colorectal cancer with cancer cachexia. Cancer cachexia is a condition where people lose weight and muscle in a way that is hard to reverse.
  • What is the main goal of the study? The main goal is to see whether HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE can help change body weight by Week 12. The study also looks at safety and tolerability.
  • What phase is the trial? This is a Phase 2 trial. Phase 2 studies usually look at whether a treatment may work and continue checking safety.
  • How is the trial designed? It is a randomized, double-blind, placebo-controlled study. Randomized means participants are assigned by chance, double-blind means neither the participants nor the study team know who gets which treatment, and placebo-controlled means one group gets a placebo, which looks like the study treatment but has no active drug.
  • How many participants are planned? The trial plans to enroll 136 participants. All participants have colorectal cancer with cancer cachexia.

Ongoing Clinical Trials on HUMANISED IGG1 MONOCLONAL ANTIBODY AGAINST GDNF FAMILY RECEPTOR ALPHA-LIKE

  • Study of NGM120 in patients with colorectal cancer and cancer cachexia: Evaluating effects on body weight

    Recruiting

    2 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia Hungary Poland Slovakia

Glossary

  • Colorectal cancer: A cancer that starts in the colon or rectum, which are parts of the large intestine.
  • Cancer cachexia: A serious condition seen in some people with cancer that causes weight loss, muscle loss, and weakness.
  • Randomized: Assigned by chance to different study groups, so the groups can be compared fairly.
  • Double-blind: A study design where neither the participant nor the study team knows who is receiving the study treatment or placebo.
  • Placebo: An inactive treatment used for comparison in a clinical trial.
  • Phase 2: A trial stage that checks early signs of benefit and continues to monitor safety.
  • Interventional study: A trial where researchers give a treatment and then measure the results.
  • Enrollment: The number of people planned to join the study.
  • Body weight: The amount a person weighs. In this trial, change in body weight is an important outcome.
  • Treatment-emergent adverse events: Health problems that happen during the study after treatment starts, whether or not they are caused by the study drug.
  • Tolerability: How well people can handle a treatment without major problems.

References